TAKING PART IN RESEARCH
INFORMATION FOR PEOPLE INTERESTED IN TAKING PART IN THE STUDY
Study title
The HELPER programme (HEalthy Living and Prevention of Early Relapse): Phase 1 (development of the intervention)
Invitation paragraph
You are invited to take part in a research study. Before you decide whether you would like to it is important for you to understand why the research is being done and what it will involve. Please take some time to read this information leaflet and discuss it with other members of your family or your care coordinator. If there is anything that is not clear, or if you would like more information, please contact one of the researchers whose details have been provided at the end of this information sheet.
Thank you for reading this.
What is the purpose of the study?
The purpose of this study is to develop a healthy living intervention that people who use Lancashire Care Early Intervention Service will want to participate in and which may help them to remain physically fit and healthy. In order to find out the views of carers about the suitability of the proposed intervention we wish to conduct interviews with individual carer and/or groups of carers.
Why have I been chosen?
We have asked care coordinators from the Lancashire Care Early Intervention Service to identify carers who they think might be interested in being interviewed about this topic.
Do I have to take part?
We are seeking volunteers who are interested in taking part in this study. It is up to you whether you want to take part or not. If you decide that you wish to participate you will be asked to sign a consent form prior to being interviewed.
What will happen to me if I take part?
If you agree to take part in the study one of our researchers will arrange a time to meet with you at a location and time which are convenient to you. At this meeting they will explain about the type of healthy living intervention that we have developed and how this will be delivered. They will then ask you some questions to find out whether you think the intervention will be acceptable to young people who use Lancashire Care Early Intervention service and whether you think the intervention will meet young people’s health education needs. With your permission the interview will be recorded, later a transcript of the interview will typed up and once this has been completed the recordings will be destroyed. Responses made by individual carers will be anonymous on the transcription.
What do I have to do?
The study has been designed to interfere as little as possible in your day to day life and having read this information sheet if you are interested in participating in the study we would be grateful if you would complete the tear off slip and return it to us in the pre paid envelope that we have sent you.
What is the procedure that is being tested?
We only want to gain your views on certain issues and participation in the study will have no effect on any other aspect of your son or daughters treatment by the Lancashire Care Early Intervention Service.
What are the side effects of taking part?
We do not anticipate that being interviewed by our researcher will have any side effects. However, if you find the interview stressful in anyway you are free to discontinue it without having to explain your reasons why.
What are the possible disadvantages and risks of taking part?
The only disadvantage of taking part in the study is giving up your time to meet with the researcher.
What are the possible benefits of taking part?
The information that you supply us with may help us to improve the healthy living intervention that we later hope to offer to young people using the Lancashire Care Early Intervention Service.
What if new information becomes available?
Not applicable
What happens when the research stops?
The information that you provide will be used to develop a healthy living intervention that will be evaluated in another study at a later date. The aim of this study will be to test the effectiveness of the healthy living intervention for young people with psychosis.
What happens if something goes wrong?
It is not anticipated that there will be any adverse events from participating in this study.
Will my taking part be kept confidential?
All information which is collected about you during the course of the research will be kept strictly confidential. Any information about you which leaves the University will have your name removed so that you cannot be recognised from it.
What will happen to the results of the study?
We hope that the results of the study will help us to develop an effective healthy living intervention for young people who use Lancashire Care Early Intervention Service.
Who is organising and funding the research?
The study is being completed by a small team of researchers led by Professor Matthew Marshall and is being funded by the National Institute for Health Research.
Who should I speak to if I am unhappy about the research or I have a complaint?
If you are unhappy about the way in which the research is being conducted or you have a complaint about one of the researchers you should speak to your care co-ordinator about your dissatisfaction. If you wish your care co-ordinator may then relay your complaint to the lead investigator Professor Matthew Marshall.
Who has reviewed the study?
The study has been reviewed by Stockport Research Ethics Committee.
Contact for further information
If you would like more information about the study or you have any questions about it please contact either of the researchers listed below.
Dr Tim Bradshaw
School of Nursing, Midwifery and Social Work
Room 6.319
University Place
Oxford Road
Manchester
M13 9PL
0161 306 7838
Dr Diane Escott
Division of Mental Health
Room 6.332
School of Nursing, Midwifery and Social Work University of Manchester
University Place
Oxford Road Manchester,
M13 9PL
diane.escott@manchester.ac.uk
Phone: +44(0)161 30 67884
Mobile: 07870 795 085
